Prescription drug · ANDA
Clemastine Fumarate NDC 64950-268
Clemastine fumarate 2.68 mg/1 · Tablet · Oral · Genus Lifesciences
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64950-268-03 | 64950026803 | 30 TABLET in 1 BOTTLE (64950-268-03)Marketed from Nov 20, 2024 | |
| 64950-268-10 | 64950026810 | 100 TABLET in 1 BOTTLE (64950-268-10)Marketed from Nov 20, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Clemastine Fumarate
- Generic name (nonproprietary)
- clemastine fumarate
- Active ingredients
- Clemastine fumarate — 2.68 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Genus Lifesciences
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073283
- Marketing start
- Listing expires
- Identifiers
- Product ID 64950-268_813d92a9-7e67-455e-9158-6aa5af5b27a7SPL ID 813d92a9-7e67-455e-9158-6aa5af5b27a7SPL set ID cf8a3449-8bb3-4d5c-8d0d-557590e49ee5RxCUI 857461UNII 19259EGQ3D
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N464950026803followed by a unit qualifier and the quantityPackage 64950-0268-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Clemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 073283
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clemszaclemastine fumarate | Clemastine fumarate 2.68 mg/1 | TabletOral | IPG Pharmaceuticals, Inc. | 71085-081 |